SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW INC., ENDOSCOPY DIV.

The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Div. with the FDA for Smith And Nephew Twinfix Ultra Ti Suture Anchor.

Pre-market Notification Details

Device IDK100159
510k NumberK100159
Device Name:SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover,  MA  01810
ContactChristina Flores
CorrespondentChristina Flores
SMITH & NEPHEW INC., ENDOSCOPY DIV. 150 MINUTEMAN RD. Andover,  MA  01810
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-20
Decision Date2010-04-19
Summary:summary

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